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Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease‐related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice. [ABSTRACT FROM AUTHOR]

Membrane transport proteins are involved in the absorption, disposition, efficacy, and/or toxicity of many drugs. Numerous mechanisms (e.g., nuclear receptors, epigenetic gene regulation, microRNAs, alternative splicing, post‐translational modifications, and trafficking) regulate transport protein levels, localization, and function. Various factors associated with disease, medications, and dietary constituents, for example, may alter the regulation and activity of transport proteins in the intestine, liver, kidneys, brain, lungs, placenta, and other important sites, such as tumor tissue. This white paper reviews key mechanisms and regulatory factors that alter the function of clinically relevant transport proteins involved in drug disposition. Current considerations with in vitro and in vivo models that are used to investigate transporter regulation are discussed, including strengths, limitations, and the inherent challenges in predicting the impact of changes due to regulation of one transporter on compensatory pathways and overall drug disposition. In addition, translation and scaling of in vitro observations to in vivo outcomes are considered. The importance of incorporating altered transporter regulation in modeling and simulation approaches to predict the clinical impact on drug disposition is also discussed. Regulation of transporters is highly complex and, therefore, identification of knowledge gaps will aid in directing future research to expand our understanding of clinically relevant molecular mechanisms of transporter regulation. This information is critical to the development of tools and approaches to improve therapeutic outcomes by predicting more accurately the impact of regulation‐mediated changes in transporter function on drug disposition and response. [ABSTRACT FROM AUTHOR]

This document is a preface to a special issue of the journal Pharmaceutics on the topic of drug transporters and their regulation and roles in therapeutic strategies. The preface provides an overview of the importance of drug transporters in human physiology and diseases, as well as in the efficacy of medicines. It highlights several articles included in the special issue that cover various aspects of drug transporters, including their structure, function, regulation, and impact on drug interactions and diseases. The preface expresses gratitude to the authors for their contributions to the field of drug transport. [Extracted from the article]

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme's interaction with the communications of health professionals and buyer's clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme. Methods: An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer's clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines. Results: Representations made directly to the public by health practitioners or on buyer's clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws. Conclusions: The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer's clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action. What is known about the topic?. The personal importation scheme has not been studied extensively. This paper investigates whether recent updates to the advertising laws will affect the operation of the personal importation scheme and health practitioners' ability to refer to it in public. What does this paper add? This paper represents the first ever analysis of the way in which the personal importation scheme interacts with health practitioners' statements, buyer's clubs, and the internet. What are the implications for practitioners ? The study finds that health practitioners who promote the availability of unapproved medicines through the personal importation scheme outside professional consultations are likely to be liable to enforcement action from the Therapeutic Goods Administration. [ABSTRACT FROM AUTHOR]

Copyright of Colección is the property of Pontificia Universidad Catolica Argentina and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This systematic review explored the multifaceted impact of drug price regulation on patient access to essential medicines. Recognizing the complexity of this relationship, the paper investigates the influence of various types of drug price regulation mechanisms, the disparities across different geographical regions and health-care systems, and the differential effects between branded and generic drugs. Our findings illustrate that the effects of drug price regulation are not universally uniform or predictable, but rather, they are highly context dependent. Direct price control measures can, on the one hand, improve accessibility through affordability; yet on the other hand, potentially disrupt drug supply. Indirect price control methods, such as reference pricing and value-based pricing, while designed to spur competition, can be hampered by administrative complexities and potentially stifle pharmaceutical innovation. Despite the pervasive use of drug price regulation, access to essential medicines remains disparate and inequitable, indicating a need for a comprehensive approach that includes health system reforms, improved health literacy, and greater collaboration between stakeholders. Future research should further investigate the enduring disparities in patient access to medicines, the long-term effects of various pricing mechanisms, and their interplay with the evolving pharmaceutical industry and health-care landscapes. [ABSTRACT FROM AUTHOR]

The medicalisation of marijuana has occurred rapidly, albeit nonuniformly, across the US and around the world over the past 3 decades. This paper centres on the medicalisation of marijuana in Minnesota—which has one of the most restrictive programs in the country—as a case for evaluating the negotiation of institutional boundaries with the shift from criminalisation to medicalisation after nearly a century of criminal prohibition. Drawing upon Foucauldian discourse analyses of the medical and law enforcement associations' position statements and legislative hearings that shaped medical marijuana policy in Minnesota, this paper demonstrates a symbiotic convergence between medicine and law enforcement through the deployment of shared discursive strategies in their opposition to medical marijuana that reinforce marijuana's criminalised status by solidifying the boundaries between proper medicine and dangerous drugs. Criminal justice and medical institutions draw upon one another's definitions, logics, and practices in a mutually constitutive manner, while still maintaining distinct user subjects and institutional interventions for each based on the user's access to state‐approved forms of marijuana. The consequences for the governing of marijuana in Minnesota are explored, as well as the broader implications for the sociological study of medicalisation and criminalisation with respect to the governance of drugs and health. [ABSTRACT FROM AUTHOR]

Narcotic drugs and substance abuse have been considered a menace across the world for many decades. The world saw drug addiction or substance abuse as a crime rather than as a medical-legal challenge faced by individuals. However, in the last few years, this perception seems to have transformed from a punitive approach to a reformatory and rehabilitative approach. Most surveys suggest that drug use peaks amongst the age group of 18-25 years. Surveys also indicate a high rate of initiation of drug use amongst adolescents. The importance of the issue is manifest from the fact that 50% of the Indian population is below the age of 25 years and around 65% is below the age of 35 years, and it is expected that the average age of the Indian population would be 29 years by the year 2020. In this paper, the authors have attempted to trace the journey of the NDPS Act and shed light on the issues such as lack of rehabilitation and pendency, which have marred the success of the Act. This paper seeks to analyse the drug laws of India which were enacted to deal with the menace of drug abuse as well as to fulfil its international obligations. Simultaneously, the authors have attempted to bring forth the key factors which seem to have shattered the intent and objectives behind this piece of legislation. The authors have weighed the Act against International Conventions and tried to test its congruity with the rehabilitative approach. Relying on various reports, domestic and global judicial developments and other reliable sources, the authors have attempted to bring forth the challenges which are being faced in dealing with the matters relating to narcotic drugs and substance abuse under the NDPS Act and other ancillary laws and provide some suggestions thereon. [ABSTRACT FROM AUTHOR]

Copyright of Collected Papers of the Faculty of Law in Split / Zbornik Radova Pravnog Fakulteta u Splitu is the property of Split Faculty of Law and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance. [ABSTRACT FROM AUTHOR]

Thailand's antimicrobial stewardship strategy has focussed on promoting 'rational drug use' in the public sector, to reduce the threat of drug resistance and control healthcare expenditure. The strategy's next ambition is to attend to the private sector, where antibiotics are widely available over the counter without prescription. Using ethnographic and survey data, this paper follows antibiotics through community pharmacies, to explore drug distribution and access, and identify potential challenges for stewardship. We extend the analytical frame beyond 'irrational' dispenser-customer transactions, to explore the logics of practice of a multiplicity of actors in the context of a highly competitive pharmaceutical market. Highlighting the role of the pharmaceutical industry in mystifying medicines, we show how antibiotics are collapsed into a category of 'strong medicines' and requested by customers using 'prescriptions by proxy'. We further examine how Thailand's drug regulation and classificatory systems, historically orientated around access to medicines, enable the proliferation of antibiotics in the context of contemporary efforts to control distribution. Recognising the negotiations involved in dispensing antibiotics in a pluralistic health system, we attempt to reconfigure allocations of responsibility, advocating for stewardship approaches that take into account local ecologies of care, as well as implications for access, equity, and accountability. [ABSTRACT FROM AUTHOR]

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country’s domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance. [ABSTRACT FROM AUTHOR]

Greek-letter student social groups, better known as fraternities and sororities, are a ubiquitous feature on many American higher education campuses. These organizations, especially fraternities, have a reputation for encouraging unruly and improper behaviour among both members and non-members. This paper investigates the effect of the degree of prevalence of these Greek organizations at a campus, as measured by the percentage of students who are members of fraternities and sororities, on the instances of liquor and drug law violations on campuses, as measured by the number of arrests for liquor and drug laws violations. Using a unique dataset, which combines data from three sources, we address any potential selection bias by including several controls associated with party culture and through the inclusion of institution-level fixed effects. We find that a larger percentage of students in fraternities (but not sororities) is associated with an increase in the number of arrests for drug law violations. A larger percentage of students in sororities (but not the percentage of students in fraternities) is associated with a larger number of arrests for liquor law violations. This result is highly significant and is robust across various specifications. [ABSTRACT FROM AUTHOR]

Tuberculosis is a chronic and lethal infectious disease caused by Mycobacterium tuberculosis. In previous decades, most studies in this area focused on the pathogenesis and drug targets for disease treatments. However, the emergence of drug-resistant strains has increased the difficulty of clinical trials over time. Now, more post-translational modified proteins in Mycobacterium tuberculosis have been discovered. Evidence suggests that these proteins have the ability to influence tuberculosis drug resistance. Hence, this paper systematically summarizes updated research on the impacts of protein acylation and phosphorylation on the acquisition of drug resistance in Mycobacterium tuberculosis through acylation and phosphorylation protein regulating processes. This provides us with a better understanding of the mechanism of antituberculosis drugs and may contribute to a reduction the harm that tuberculosis brings to society, as well as aiding in the discovery of new drug targets and therapeutic regimen adjustments in the future. [ABSTRACT FROM AUTHOR]

Although college enrollment and completion rates have increased over the past 30 years, access to higher education has not been uniform across racial groups. In addition to racial gaps, differences in tertiary education outcomes exist by gender. Gender gaps in college enrollment are larger in the Latinx community than in other racial or ethnic groups. In this paper, we use the October Current Population Survey (CPS) supplements for the years 1984–1992 and state and federal drug laws to measure the impact of the passage of the 1986 Anti-Drug Abuse Act on the likelihood of college enrollment for young Latino men. Following the passage of the federal law, some states changed their drug laws around marijuana and cocaine possession and distribution. We use this variation in state law in order to explore whether states that have more lenient marijuana and cocaine laws also have a higher likelihood of college enrollment. We find that there was a four percentage point decline in both the likelihood of high school completion and that of college enrollment for Latinx men after the passage of the 1986 Anti-Drug Abuse Act. Findings have implications for modifications to state drug laws and addressing the ways in which these laws impact educational attainment for students underrepresented in higher education. [ABSTRACT FROM AUTHOR]

This paper uses SIDE theory and an information seeking lens to examine the types of information and support messages (N = 126,977 posts) veterans seek on the social networking site Reddit regarding medical marijuana use. A combination of automated text analysis strategies paired with thematic analysis produced eight themes: Doctor Patient Conversations, Drug Test, Legality, Legal Policy, Prescription Drug Use/Other Substance Use, Point of View, Reasons for Use, and V.A. Findings reveal that a large portion of veterans discuss how medical marijuana can be used to self-medicate for a number of issues, including PTSD, anxiety, and sleep deprivation. Results also highlighted missing topics within veterans' conversations about medical marijuana use. For instance, veterans rarely discuss the strategies they use to talk to their doctor about their medical marijuana use. Practical implications and directions for future research are offered. [ABSTRACT FROM AUTHOR]

Inflammation is a possible cause of variability in drug response and toxicity due to altered regulation in drug‐metabolizing enzymes and transporters (DMETs) in humans. Here, we evaluate the clinical and in vitro evidence on inflammation‐mediated modulation of DMETs, and the impact on drug metabolism in humans. Furthermore, we identify and discuss the gaps in our current knowledge. A systematic literature search on PubMed, Embase, and grey literature was performed in the period of February to September 2020. A total of 203 papers was included. In vitro studies in primary human hepatocytes revealed strong evidence that CYP3A4 is strongly downregulated by inflammatory cytokines IL‐6 and IL‐1β. CYP1A2, CYP2C9, CYP2C19, and CYP2D6 were downregulated to a lesser extent. In clinical studies, acute and chronic inflammatory diseases were observed to cause downregulation of CYP enzymes in a similar pattern. However, there is no clear correlation between in vitro studies and clinical studies, mainly because most in vitro studies use supraphysiological cytokine doses. Moreover, clinical studies demonstrate considerable variability in terms of methodology and inconsistencies in evaluation of the inflammatory state. In conclusion, we find inflammation and pro‐inflammatory cytokines to be important factors in regulation of drug‐metabolizing enzymes and transporters. The observed downregulation is clinically relevant, and we emphasize caution when treating patients in an inflammatory state with narrow therapeutic index drugs. Further research is needed to identify the full extent of inflammation‐mediated changes in DMETs and to further support personalized medicine. [ABSTRACT FROM AUTHOR]

Cannabis liberalization is a fascinating case study in moral-legal re-negotiation. From broad international examples of decriminalization to specific local legalization models, numerous criminological questions are emerging. This paper describes three significant challenges for cannabis liberalization. These include persistent inequalities associated with policing cannabis, the invisibility of coercive care and control within diversion, and the hazards associated with illusory policy reform. We present Cannabis Criminology as a multidisciplinary effort to understand the prohibition, decriminalization, legalization, and nascent regulation of cannabis in ways that acknowledge but transcend law-based paradigms. Consistent with criminology's multiple and sometimes contradictory dimensions, we outline five thematic areas that can inform the study of cannabis. These include law, society, and social control, police and policing cannabis, race, ethnicity and intrusion, the economics of cannabis use, and cannabis and criminal behavior. Finally, we conclude that privileging the views of people who use cannabis can provoke more inclusive, participatory, and otherwise imaginative efforts. [ABSTRACT FROM AUTHOR]

Copyright of Angle Health Law Review is the property of Angle Publishing Co., Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow. [ABSTRACT FROM AUTHOR]

The paper focuses on the development of a multifractal theoretical model for explaining drug release dynamics (drug release laws and drug release mechanisms of cellular and channel-type) through scale transitions in scale space correlated with experimental data. The mathematical model has been developed for a hydrogel system prepared from chitosan and an antimicrobial aldehyde via covalent imine bonds. The reversible nature of the imine linkage points for a progressive release of the antimicrobial aldehyde is controlled by the reaction equilibrium shifting to the reagents, which in turn is triggered by aldehyde consumption in the inhibition of the microbial growth. The development of the mathematical model considers the release dynamic of the aldehyde in the scale space. Because the release behavior is dictated by the intrinsic properties of the polymer–drug complex system, they were explained in scale space, showing that various drug release dynamics laws can be associated with scale transitions. Moreover, the functionality of a Schrödinger-type differential equation in the same scale space reveals drug release mechanisms of channels and cellular types. These mechanisms are conditioned by the intensity of the polymer–drug interactions. It was demonstrated that the proposed mathematical model confirmed a prolonged release of the aldehyde, respecting the trend established by in vitro release experiments. At the same time, the properties of the hydrogel recommend its application in patients with intrauterine adhesions (IUAs) complicated by chronic endometritis as an alternative to the traditional antibiotics or antifungals. [ABSTRACT FROM AUTHOR]

The word "psychedelic" (psyche (i.e., the mind or soul) and delos (i.e., to show)) has Greek origin and was first coined by psychiatrist Humphry Osmond in 1956, who had been conducting research on lysergic acid diethylamide (LSD) at the time. Psychedelic drugs such as N,N-DMT/DMT (N,N-dimethyltryptamine), 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine), LSD (lysergic acid diethylamide), MDMA (3,4-methylenedioxymethamphetamine) and psilocybin have had significant value as an entheogen in spiritual, religious (shamanic) and sociocultural rituals in Central and South American cultures for thousands of years. In the 1960s, the globalization of these drugs and their subsequent spread outside of their indigenous, old-world cultures, led to the subsequent implementation of strict drug control laws in many Western countries. Even today, psychedelics are still classified as Schedule I drugs, resulting in a still lingering negative stigmatization/perception, vilification, and ultimate criminalization of psychedelics. This controversy still lingers and still limits scientific research and full medical acceptance. For many years up until recently, the spiritual, religious and medicinal value of these drugs could not be explored in a scientific context. More recently, a second wave of psychedelic research is now focusing on psychedelics as neuropharmaceuticals to treat alcohol and tobacco addiction, general mood and anxiety disorders and cancer-related depression. There is now a vast array of promising evidence-based data to confirm the years of anecdotal evidence of the medicinal values of psychedelics. Natural therapeutic alternatives such as psychedelic drugs may provide a safe and efficacious alternate to conventional drugs used to treat mood and anxiety disorders. In a Western context in particular, psychedelic drugs as therapeutic agents for mood and anxiety disorders are becoming increasingly of interest amidst increasing rates of such disorders globally, changing social constructions, the implementation of government regulations and increasing investment opportunities, that ultimately allow for the scientific study to generate evidenced-based data. Alternative psychotherapeutic interventions are gaining interest also, because of their low physiological toxicity, relatively low abuse potential, safe psychological effects, and no associated persisting adverse physiological or psychological effects during and after use. On the other hand, conventional psychotic drugs and anti-depressants are becoming less favorable because of their adverse side effects. Psychedelic neuropharmaceutical interventions may with medical oversight be the solution to conventional psychiatric disorders such as depression and anxiety, and an alternative to conventional psychiatric treatment options. This paper will review the therapeutic potential of psychedelic drugs as alternative therapeutic options for mood and anxiety disorders in a controlled, clinical setting, where the chances of adverse psychological episodes occurring are mitigated. [ABSTRACT FROM AUTHOR]

Using the 'war on drugs' in Colombia as its case study, this paper reflects on the recent findings and recommendations of Colombia's Truth Commission to make a case for a transformative approach to end ongoing cycles of drugs-related violence. In Colombia, the armed conflict and repressive prohibitionist drug policies are deeply entangled, and violence is ongoing. A peaceful future, we contend, requires thinking about a world in which we can live well with drugs. This would be a clear break from the goal of a 'drug free' world that has prevailed under the repressive prohibitionist regime. Legal regulation of drug markets is proposed here as a form of long-overdue reparations for victim groups in Colombia, which could address and repair past inequality and harms engendered by prohibition, and improve the living conditions of people involved in, and impacted by, illegal drug markets. Colombia, with its unique historical trajectory, has much to contribute towards future projections on the global legal regulation of drug markets. By positioning legal regulation of drug markets as reparation, this paper contributes to debates on drug policy reform and reparative justice, arguing that the two are very much connected. • The Colombian truth commission (CEV) concluded that the county's conflict has been transformed by the 'war on drugs'. • This chapter analyses the CEV's recommendation to transition towards a legally regulated drug market to end violence in Colombia. • Drug policy reform is not an end in itself; it should help to create a fairer and more inclusive world. • This chapter makes an important contribution from the Global South to debates about drug legalisation. [ABSTRACT FROM AUTHOR]

A balanced approach using an integrated combination of strategies, namely, demand reduction, supply reduction and harm reduction, was suggested to be implemented in a balanced way to the policy vision of a South Africa 'free of substance abuse'. Responding on the call for a comprehensive review of the National Drug Master Plan 2013–2017 to ensure consistency in policy approach, this article explores the integrative propositional analysis (IPA)‐based analysis to evaluate 'how systemic' and integrated were the policy strategies applied. The analysis draws insights from the internal consistency of the policy and provides complementary evidence on the systemic breakdown of the policy, which correlates with previous studies. The findings are indicative of the usefulness of the IPA‐based tools to more pragmatically develop policy that better reflects the systemic/integrated relationship of the three strategies based on their conceptual systemic integrity. This research has implications for interdisciplinary scholars and practitioners, of policy and theory. [ABSTRACT FROM AUTHOR]

Background: Regulatory assessment of anthroposophic medicinal products (AMPs) can be challenging due to their specific features. Objective: The aim of this paper is therefore to provide adequate scientific information on AMPs for regulatory purposes. Methods: A literature review was executed with database searches in PubMed, Cinahl, Merkurstab, Anthromedics, and https://iaap-pharma.org/. Search terms were: anthroposophic medicinal products, anthroposophic medicines, anthroposophic pharmacy. There was no language restriction; searches were executed from onset until June 11, 2020. In addition, experts were invited to suggest relevant literature. Results: Eighty-seven of 660 identified publications were included. The system of anthroposophic medicine (AM) with its conceptual background and various aspects of AMPs was described: definition, pharmaceutical properties, an example of AMP development, use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, scientific and regulatory assessment. Conclusion: AMPs are part of the integrative whole medical system of AM. AMPs are manufactured according to Good Manufacturing Practice and national drug regulations and have an excellent safety status; the limited available evidence suggests clinical benefits. Current drug regulation of AMPs in the EU and most European countries does not take the special properties of AMPs into account. Future research should focus on appropriate methodologies for the evaluation of effects of AMPs as part of the AM whole medical system, the scientific quality of its non-atomistic holistic ontological position, and the integration of AM and conventional medicine in clinical practice. Future policies should focus on appropriate ways of addressing regulatory challenges to AMPs. [ABSTRACT FROM AUTHOR]

Throughout history, medicinal and aromatic plants have been used extensively to cure a variety of ailments. This article provides a comprehensive overview of Cannabis sativa, specifically focusing on its legislative status, decriminalization, phytochemistry, antimicrobial activity, and safety. The study begins by briefly outlining the plant's history, including its cultivation, harvesting, and storage methods. The review analyzes extensively the antimicrobial properties of Cannabis sativa and its derivatives, specifically examining their reported antiviral, antibacterial, antifungal, and antiparasitic capabilities, which have been documented in databases such as Scopus, ScienceDirect, PubMed, and Web of Science. The paper also discusses trends in studies about the plant object of the study, the different bioactive compounds that were identified in the plant (phenolic acids, flavonoids, alkaloids, cannabinoids, and terpenes), and safe consumption in several cannabis-based products including candies, desserts, wine and as food flavoring. Furthermore, this study has reported information about the legalization and decriminalization of cannabis use across the globe with a specific focus on Morocco because it has the largest cultivated area of C. sativa plant. However, some substances with potential antimicrobial properties were not investigated in this review due to the lack of data on their activity. The authors hope that their efforts will inspire future studies on the therapeutic uses of Cannabis sativa and its derivatives, ultimately leading to improved health outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Access to medication for opioid use disorder (MOUD) varies across the rural-urban continuum. The Hub & Spoke Model (H&S) emerged to address these gaps in service whereby hubs with staff expertise in MOUD support delivery of specialized care to a network of spoke locations, often located in rural communities with workforce shortages. This paper presents a case study of efforts to implement the hub and spoke model in a frontier and rural (FAR) state: Montana. Methods: The primary data are structured interviews with 65 MOUD program staff in hub and spoke locations within Montana. Both inductive and deductive coding were used to analyze the transcripts. Findings: Using the H&S structure to expand access to MOUD in Montana led to mixed results. There were consistent themes identified in the interviews about the reasons why hubs struggled to successfully recruit spokes, including (1) geographic barriers, (2) a lack of interest among medical providers, (3) fears about excessive demand, (4) concerns about the financial viability of the model, and (5) a preference for informal technical assistance rather than a formal H&S relationship. In addition to these 5 themes, efforts to implement H&S across different medical systems were unsuccessful, whereas the H&S model worked more effectively when H&S locations were within the same organization. Conclusion: This case study identified limits to the H&S model utility in supporting states' abilities to expand access to MOUD treatment and offers suggestions for adapting it to accommodate variation across divergent rural contexts. We conclude with recommendations for strategies that may assist in expansion of MOUD in rural communities that are like those found in Montana. [ABSTRACT FROM AUTHOR]

Synthetic cannabinoids (i.e. Spice) are a major public health problem in UK prisons, however, research in this area is limited. Here we aimed to draw comparisons between people with and without experience of using synthetic cannabinoids in prison, to characterise the features of, and motivations for use within this setting and evaluate support for different treatment interventions. Questionnaires were administered to 122 people in a category-B prison for adult males in England between July 2022 and March 2023. Participants were asked questions related to their sociodemographic and custodial characteristics, use of synthetic cannabinoids (and other drugs) inside and outside of prison and psychological distress was measured via the Brief Symptom Inventory (BSI-18). Those that had ever used synthetic cannabinoids in prison completed additional questions related to features of use, motivations for use and support for various interventions. In total 46.7 % (n = 57) of participants reported use of synthetic cannabinoids in prison and this group experienced significantly greater levels of psychological distress compared to those reporting no use (mean (± standard deviation) BSI-18 scores = 23.7 (±16.7) vs 12.8 (±13.6), p < 0.001). Participants mostly reported using paper-based preparations (77.4 %) and use via e-cigarettes (75.9 %). The most strongly endorsed motivations for use included to alleviate boredom (91.1 % strongly agree/agree), to make the sentence pass faster (89.3 % strongly agree/agree) and to cope with stress (80.4 % strongly agree/agree). The interventions that received most support were strategies to better manage time and medication to manage withdrawal. The use of synthetic cannabinoids in UK prisons typically involves the use of paper-based preparations via e-cigarettes, and use is associated with greater levels of psychological distress. Motivations for use were mostly pragmatic (e.g. to alleviate boredom or cope with stress) and interventions should prioritise increasing the time individuals spend out of cells and in meaningful activity. [ABSTRACT FROM AUTHOR]

This article expands upon a session, titled "Implications of Pediatric Initiatives on CNS Drug Development for All Ages--2020 and Beyond," that was presented as part of a two-day meeting on pediatric drug development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs. The speakers wrote summaries of their talks, which are included here. The session's lead chair was Dr. Gahan Pandina, who wrote introductory and closing comments. Dr. Joseph Horrigan addressed the current landscape of pediatric development programs. Dr. Gahan Pandina addressed how the approach to research in pediatric populations affects the drug development process and vice versa. Dr. Alison Bateman-House discussed the ethical implications of research in the pediatric population. Dr. Luca Pani discussed some of the global regulatory issues and challenges concerning research in pediatric patients. Dr. Judith Kando served as a discussant and posed new questions about means of facilitating pediatric research. Finally, Dr. Gahan Pandina provided closing comments and tied together the presented issues. This paper should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and/or required, through regulations, to include children as part of the approval process. [ABSTRACT FROM AUTHOR]

Global momentum for drug law reform is building. But how might such reform be achieved? Many argue that human rights offer a possible normative framework for guiding such reform. There has been very little research on whether human rights processes can actually achieve such aims, however. This paper responds to this knowledge gap. It explores how one human rights mechanism—the "parliamentary rights scrutiny process"—deals with alcohol and other drugs. We consider how four Australian parliaments scrutinized proposed new laws that would deal with alcohol and other drugs for their human rights "compatibility." We find that laws that would limit the rights of people who use alcohol and other drugs were routinely seen as justifiable on the basis that alcohol and other drugs were inherently "unsafe." Crucially, safety was conceptualized in a gender-neutral way, without regard to the potential role of gender, including specific masculinities, in the production of phenomena such as family violence and sexual violence and other public safety problems. Instead, such problems were regularly constituted as consequences, simply, of alcohol or other drug consumption. In making this argument, we build on the pioneering work of David Moore and colleagues (e.g., 2020). Their work asks important questions about how the causes of violence are constituted across different settings, including research and policy. Drawing on ideas from scholars such as Carol Bacchi and John Law, they identify "gendering practices" and "collateral realities" in research and policy on violence, in which the role of men and masculinities are routinely obscured, displaced or rendered invisible. We find similar problems underway within human rights law. In highlighting these gendering practices and collateral realities, we aim to draw attention to the limitations of some human rights processes and the need for more work in this area. [ABSTRACT FROM AUTHOR]

Many nations and jurisdictions have legalized non-medical adult use of cannabis, or are considering doing so. This paper contributes to knowledge of adult use legalization's associations with cannabis use disorder (CUD) treatment utilization. This study collected data from a dataset of all publicly funded substance use disorder treatment delivered in California from 2010 to 2021 (1,460,066 episodes). A logistic regression model estimates adult use legalization's impacts on CUD treatment utilization using an individual-level pre-post time series model, including individual and county-level characteristics and county and year-fixed effects. Adult use legalization was associated with a significant decrease in the probability of admission to CUD treatment (average marginal effect (AME): −0.005, 95 % CI: −0.009, 0.000). Adult use legalization was also associated with a decrease in the probability of admission to CUD treatment for males (AME: −0.025, 95 % CI: −0.027, −0.023) Medi-Cal beneficiaries (AME: −0.025, 95 % CI: −0.027, −0.023) adults ages 21+ (AME: −0.011, 95 % CI: −0.014, −0.009) and Whites (AME: −0.012, 95 % CI: −0.015, −0.010), and an increase in the probability of admission to CUD treatment for patients referred from the criminal justice system (AME: 0.017, 95 % CI: 0.015, 0.020) and Blacks (AME: 0.004, 95 % CI: 0.000, 0.007) and Hispanics (AME: 0.009, 95 % CI: 0.006, 0.011). Adult use legalization is associated with declining CUD treatment admissions, even though cannabis-related problems are becoming more prevalent. Policies and practices that protect public health, and engage people with CUD in treatment are needed. • Pre-legalization, 19 % of SUD admissions were CUD, compared to 9 % post-legalization. • Adult use legalization was associated with a decrease in CUD treatment admissions. • Differences existed in legalization's associations on different demographic groups. [ABSTRACT FROM AUTHOR]

This article tests the impact of deterrence and normative variables in the estimation of drug use among both detected drug users and university students. Consistent with perceptual deterrence research, we expect: (a) a stronger effect of normative variables on estimation of drug use compared to deterrence variables and (b) that any deterrent effect would be restricted to detected drug users. In Portugal, we conducted a cross-sectional survey with detected drug users (N = 147) and with a sample of university students (N = 247). The main results show that normative variables outperform deterrent variables as predictors of intention to use drugs. Descriptive norms have a greater influence on the estimation of drug use in both groups, and proximal social norms have robust effects among university students. Core elements of the deterrence model are not related to the intention to use drugs. Personal certainty of being caught has even an unexpected positive correlation with this intention. A small deterrent effect is limited to the general certainty variable and only among more law-abiding people. The overall findings are consistent with a normative perspective on law compliance and highlight the importance of including all different normative and deterrent variables in models estimating drug use. [ABSTRACT FROM AUTHOR]

• First trends analysis of data from the national Canadian Cannabis Survey. • Past-year cannabis use increased since non-medical cannabis legalization in Canada. • The proportion of past-year consumers using cannabis frequently is unchanged. • Past-year use of edibles, drinks and vape pens/cartridges has increased. • Legal purchasing is displacing the illicit cannabis market in Canada. Cannabis use for non-medical purposes was legalized and regulated in Canada through the Cannabis Act in October 2018. This paper examined trends in use of cannabis for non-medical purposes and related indicators from pre- to post-legalization in Canada (2018–2022). Data from 5 years of the Canadian Cannabis Survey, an annual web-based survey administered to Canadians 16 years of age or older, were used in the analysis (n 2018 =12,952; n 2019 =11,922; n 2020 =10,821; n 2021 =10,733; n 2022 =10,048). Cannabis measures include questions about use, types of products, sources, risk perceptions and beliefs, and exposure to public education campaigns and health warnings. Adjusted logistic regression models tested differences in outcomes over time. Past 12-month cannabis consumption increased among Canadians from 22 % in 2018 to 27 % in 2022 (AOR=1.41;99 % CI:1.28–1.54). Similarly, daily/almost daily (DAD) consumption increased from 5 % in 2018 to 7 % in 2022 (AOR=1.36;99 % CI:1.16–1.59). Consumption of dried flower, hash/kief, and concentrates/extracts (e.g., wax, shatter, budder) decreased since 2018, whereas consumption of edibles, beverages and vape pens/cartridges increased (p < 0.001). Legal purchasing increased from 4 % in 2018 to 69 % in 2022, while accessing cannabis through social and illegal sources decreased over time (p < 0.001). More Canadians are reporting cannabis consumption since legalization and regulation of cannabis for non-medical purposes, continuing a pre-existing trend despite an increase in awareness of the risks of consuming cannabis. Trends in product use indicate a transition from dried flower and concentrates/extracts towards consumption of cannabis foods, drinks and vape pens/cartridges. The legal market is increasingly displacing the illicit cannabis market in Canada. [ABSTRACT FROM AUTHOR]

There have been several recent commentaries which have highlighted the relevance of the postcolonial perspective to drug prohibition and called for the decolonisation of drug policy (Daniels et al., 2021 ; Hillier, Winkler & Lavallée, 2020 ; Lasco, 2022 ; Mills, 2019). While these are significant interventions in the field, sparse drugs scholarship has engaged more directly with well-developed literature and concepts from Critical Indigenous Studies (Moreton-Robinson, 2016) and Indigenous Standpoint Theory (Moreton-Robinson, 2013 ; Nakata, 2007) and reflected on its applicability to the drug and alcohol field. In contrast to the postcolonial perspective, which understands colonisation as a historical event with contemporary impacts, Indigenous scholarship conceptualises colonisation as an active and ongoing part of how the settler-state continues to impose itself. From this vantage point I explore coloniality as a system of power and reflect on the way prohibition acts as a key arm of the settler-colonial state. The paper explores the way concepts like vulnerability, marginality, overrepresentation, disproportionality and addiction involve colonial violence, knowledge practices and narratives which are central to the way coloniality is maintained and continues to assert itself in contemporary settler societies. [ABSTRACT FROM AUTHOR]

Real world evidence (RWE) has the potential to inform drug discovery, development, and regulatory decision making. The emergence and availability of large population‐based datasets around the globe have stoked enthusiasm in the research community. However, much work remains to refine research methodologies, evolve the science, and define the place of RWE as a complementary source of evidence to randomized controlled trials. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [ABSTRACT FROM AUTHOR]

Since 2011, the misuse or abuse of etomidate has gradually increased when propofol was designated a controlled drug under the Narcotics Control Act in Korea. Accordingly, the Ministry of Food and Drug Safety announced that etomidate would be under the 'Regulation on the designation of drugs that may cause concerns of misuse or abuse' rule in June 2020, which is less stringent than the Narcotics Control Act. Therefore, this review investigates potential misuse or abuse cases of etomidate to consider strengthening its management. A literature search was conducted to compare etomidate with other sedatives in their efficacy and side effects, as well as identify the adverse health outcomes, abuse cases, and analytical methods of etomidate. Etomidate has an equal or higher sedative efficacy and lower risk of adverse cardiopulmonary events than propofol. However, major adverse effects of etomidate include adrenocortical suppression and unproven associated deaths, as well as myoclonus requiring pre-treatment. Although the issue of abuse and misuse of etomidate is emerging in recent years, there are few academic reports on these issues and analytical methods in the forensic field. In order to effectively manage the misuse or abuse of etomidate, it is necessary to continuously monitor related cases with great interest and to be more intensively studied on its abuse potential. [ABSTRACT FROM AUTHOR]

In several controversial drug approval decisions in recent years, the Food & Drug Administration ("FDA") has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency's determination whether a drug is "safe" and "effective" does not seem to depend on whether its approval also supports innovation. But FDA'suse of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of its regulation of drugs. In this Article, we investigate the broad set of innovation-related judgments that FDA has been making and argue that there are serious concerns with the major innovation role FDA has been playing, at least as the Agency is currently constituted. We conclude that FDA should not separately weigh innovation in decisions about a product's safety and effectiveness. In other areas, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in shaping the development of novel drugs. But policymakers should do so while thoughtfully considering both the opportunities and challenges of FDA actively considering innovation incentives in its decisions; those challenges have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit the ways that FDA considers innovation in its regulatory decisions, changes are needed to the Agency's structure to support its ability to make reasoned judgments based on relevant expertise. [ABSTRACT FROM AUTHOR]

• The Norwegian government proposed a drug decriminalization reform. • The shift from the justice sector to the health sector would only be partial. • The police would retain their role in drug law enforcement after the reform. • Illicit drug use continued to be fundamentally pathologized in the proposed reform. • The most profound aspect of the reform was its emphasis on consent in interventions. In 2018 the Norwegian government appointed a committee to prepare the implementation of a drug decriminalization reform. The overall goal of the committee was to propose a model where responsibility for society's response to the use and possession of illegal drugs for personal use would be transferred from the justice sector to the health service, under the catchphrase 'from punishment to help'. While the proposal ultimately did not get the necessary backing in parliament, the proposed reform still constitutes a very comprehensive and recent proposal for reforming national drug policy and it provides an ideal case for studying contemporary discourses on 'drug decriminalization'. The analysis of this reform proposal is guided by the post-structuralist "What's the Problem Represented to be" (WPR) approach, which is used for investigating the problem representation(s) in the proposal, as well as the rationalities, practices and deep-seated assumptions underpinning these. In doing this, the paper explores how the strategy represents both changes and continuities in discourses around illicit drugs and the people who use them. Based on the WPR approach, two problem representations in the proposal are identified: the 'problem of illicit drug use' and the 'problem of criminalization'. However, the 'problem of illicit drug use' is argued to be the authoritative representation, that takes precedence over the other. In that regard, the paper points to how the proposed shift from the justice sector to the health sector would only be partial, given that the role of the police and drug law enforcement would be retained in the reform. Furthermore, the paper points to how illicit drug use continued to be fundamentally pathologized in the proposed reform. The paper concludes with a discussion about the overall ambition of shifting from a crime-centered to a health-centered approach to people who use drugs and some reflections on the potential of an additional rights-based approach is provided. [ABSTRACT FROM AUTHOR]

• Random drug testing in schools has been part of Philippine policies since the 2000s. • During Duterte's drug war, it was implemented and scaled up by education agencies. • It has impacted students by placing them at risk of stigma and fatal violence. • It has impacted schools by necessitating human and financial resources. • Drug testing in schools has political and social efficacy amid a drug-free paradigm. With the stated aims of promoting "drug-free" campuses and "instilling in the minds of students" that drugs are harmful, drug testing in schools has been a feature of the Philippines' punitive drug regime for two decades, gaining prominence during the Duterte administration's war on drugs (2016-2022). Drawing on key informant interviews and a desk review of news articles and official documents, this paper presents a historical overview of this policy as well as its impacts on students, educational institutions, and Philippine society. The paper finds that the group most affected by drug testing in schools are the students themselves, who are placed at risk of discrimination and alienation. Schools are also affected by the policy, as it requires expending their human and financial resources. More broadly, the policy perpetuates longstanding popular notions on drugs, children, and the overall idea that individuals carry the "burden of proof" to demonstrate their worthiness for societal inclusion. Drug testing in Philippine schools is ineffective and misguided in its objectives, but it has received widespread support because of its social and political efficacies. [ABSTRACT FROM AUTHOR]